Pangaea Express: One Step Closer to Drug Importation

December 24, 2019

By Marla Weingarten

Late last week, the U.S. came one step closer to allowing drugs to be imported from Canada. The President, along with the HHS and FDA, issued a notice of proposed rulemaking (NPRM) to allow the importation of certain prescription drugs from Canada. There remain the 2 pathways as outlined in the Safe Importation Action Plan announced last July 2019.

Pathway 1 identifies the process by which states and other non-federal government entities could submit an importation program proposal to manage the importation of certain drugs (currently marketed in the U.S.) from Canada. Any eligible prescription drug would need to be relabeled for U.S. requirements, and tested for authenticity, degradation etc.

This importation program (as described in Section 804 of the FD&C Act) identifies the “Foreign Seller” as the entity that will purchase the eligible drug directly from its manufacturer and sell directly to the importer in the U.S. “Under the proposed rule, Foreign Sellers would be required to be licensed by Health Canada as drug wholesalers and be registered with a provincial pharmacy regulatory authority to distribute [Health Canada’s Health Products and Food Branch] HPFB-approved drugs.” Section 804 of the FD&C Act also identifies post-importation regulations that include a written recall plan that describes the procedures to perform a recall of the product and specifies who will be responsible for performing the procedures.

Pathway 2 is the process by which manufacturers are able to import versions of FDA-approved drugs sold in foreign countries into the U.S. Along with the NPRM issued last week, the Feds published a new draft guidance for industry that describes procedures manufacturers will need to follow to import prescription drugs, including biologics that are manufactured abroad. This new guidance (under Section 801(d)(1)(B) of the FD&C Act), issued December 2019, describes the process by which manufacturers could obtain an additional National Drug Code (NDC) for certain FDA-approved prescription drugs.

Comments on the NPRM are being accepted for 75 days after publication in the Federal Register and comments on the draft guidance (for drug manufacturers to follow to facilitate importation) are being accepted for 60 days after publication in the Federal Register.

So where are we regarding timing before the flood gates open? With a 75-day consultation period it is possible that the importation of drugs into the U.S. could become law by early spring. As we know, Florida has already submitted their importation plan proposal to the HHS, and as such, they may be the first state to introduce drug importation. Is it any coincidence the timing of this may line up nicely with the President’s campaign for re-election? He must be itching to announce the legal importation of drugs to Florida - this essential state to win over.

For more information, please contact Marla Weingarten.